COBAS® AmpliPrep/COBAS® TaqMan® CMV Test

Improve patient management and treatment success

Reliably monitor Cytomegalovirus infection

Cytomegalovirus (CMV) is a leading cause of morbidity and mortality in transplant recipients. Severe CMV infection in high risk patients may develop soon after transplantation and without effective treatment, may lead to CMV syndrome, tissue invasive disease, and potential rejection or loss of the graft.1

The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test reliably monitors Cytomegalovirus infection and is proven to provide comparable and reproducible viral load results across different institutions, over several orders of magnitude. It is the first standardized CMV viral load test with CE and FDA approval.2

You can realize the following benefits for your laboratory and clinicians:

Standardization

The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test demonstrates co-linearity to the WHO international standard, reporting results in IU/mL as recommended by the international consensus guidelines for CMV management in solid organ transplant patients.1,3 It helps bring standardization to sample type (plasma) for testing and delivers results that align across institutions to optimize CMV management.

Clinical Validation

Roche CMV tests have been central in clinical studies for current treatment regimens and those in development. Extensive studies were conducted in the development of the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test, including clinical trials required to demonstrate clinical utility. The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is referenced in the International Consensus Guidelines for the Management of CMV in SOT patients (2013) through a multi-center study conducted by Hirsch, et al.4

Automation

The generation and maintenance of an LDT takes time and effort on the part of the laboratory, and places the burden and associated risk for quality compliance and troubleshooting on the laboratory.5,6The COBAS®AmpliPrep/COBAS® TaqMan®CMV Test is validated with ready-to-use reagents, performed on a fully automated platform solution, and includes calibration.7,8

Setting the standard in monitoring CMV infection

Enhance the picture of CMV control with the assurance your clinicians need in clinical decision making without the need to manage the complexity of lab developed tests. The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test offers traceability to the international WHO Standard.

Note: The FDA has approved the testing of blood samples for the Zika virus using the cobas®Zika test under a specific protocol by U.S. blood screening laboratories.9 For use on cobas®6800/8800 Systems, the cobas® Zika test under a specific protocol by U.S. blood screening laboratories.

Intended use

Intended use

(CE-IVD)

The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is an in vitro nucleic acid amplification test for the quantitation of cytomegalovirus DNA in human plasma using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or COBAS® TaqMan® 48 Analyzer for automated amplification and detection. The test can quantitate CMV DNA over the range of 150 – 10,000,000 copies/mL. One copy of CMV DNA (as defined by the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test) is equivalent to 0.91 International Unit (IU) on the First WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC 09/162).

The test is intended to be used in conjunction with clinical presentation and other laboratory markers in the diagnosis and management of CMV infection in patients at risk for CMV disease.

The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is not intended for use as a screening test for the presence of CMV in blood or blood products or as a diagnostic test to confirm the presence of CMV infection. The results from the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test must be interpreted within the context of all relevant clinical and laboratory findings.

(US-IVD)

The COBAS®AmpliPrep/COBAS® TaqMan® CMV Test is an in vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (CMV) DNA in human EDTA plasma using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or the COBAS® TaqMan® 48 Analyzer for automated amplification and detection.

The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is intended for use as an aid in the management of solid-organ transplant and hematopoietic stem-cell transplant patients who are undergoing anti-CMV therapy. In this population serial DNA measurements can be used to assess virological response to antiviral treatment. The results from the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test must be interpreted within the context of all relevant clinical and laboratory findings.

The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is not intended for use as a screening test for the presence of CMV DNA in blood or blood products.

This website contains information on products which is targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. Please be aware that we do not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.